Quality Management

for the Medical Laboratory

Michael Noble MD FRCPC
Chair Program Office for Laboratory Quality Management
Medical Director for Quality LifeLabs BC

January 2009

Books Worth Reading

The Deming Method by M. Walton (1986)

ISO 9000 Essentials CSA
ISO 15189:2003 Essentials CSA
CLSI HS1
CLSI GP26:A3

January 2009

Outline

Why Medical Labs need Quality Management

Abbreviated History of Quality Management
Historys evolution to Standards and Guidelines
Quality Partnerships
Progress to the Quality Toolbox

January 2009

Seventy percent of
clinical medicine decision making is
predicated upon, or confirmed by,
or documented by
medical laboratory test results.

Dighe, A. S.,
Medicolegal liability in laboratory medicine,
Semin Diagn Pathol, 2007

January 2009

 In the United States there are between 7

and 10 Billion laboratory tests reported
annually.
Boone DJ, IQLM, 2005

15% of patients in a 5 country study receive

either incorrect or delayed reports on
abnormal results.
Boone DJ, IQLM, 2005

January 2009

Why Medical Labs need Quality

Management
Medical Laboratories
Highly complex operations
Individuals doing complex tasks
Absolute need for Accuracy
Absolute need for Confidentiality
Absolute need for Time Effectiveness
Absolute need for Cost Effectiveness

January 2009

But lots of evidence to the

contrary
Belk and Sunderman (1947)
CLIA 66
CLIA 88
Maryland General
Newfoundland
Manitoba

January 2009

Quality Management is not new

1922 - Walter Shewhart
Statistical
Process Control

ACT

PLAN

CHECK

DO

January 2009

Management Principles
1940 - J Edwards Deming - The Fourteen Points
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.

Create constancy of purpose of product and service

Adopt a new philosophy (mistakes are unacceptable)
Cease dependence on mass inspection
Stop the process of awarding business on price alone.
Improve constantly and forever the production and service
Institute training
Institute leadership
Drive out fear
Break down barriers between staff areas.
Eliminate slogans and targets
Eliminate numerical quotas
Remove barriers to pride in workmanship
Institute vigorous education and retraining

14.

Take action to accomplish the transformation

January 2009

J Edwards Demining The seven deadly diseases

1.
2.
3.
4.
5.
6.
7.

Lack of constancy of purpose

Emphasis on short term profits
Evaluation by performance
Mobility of Management
Running a company on visible figures alone
Excessive medical costs
Excessive costs or warranty

January 2009

10

 In the U.S. industry did not want to listen

But Japan did.Deming visits
Japan
electronics
US Automotive

US
electronics

Motorola
Digital

Japan automotive
1920
January 2009

1940

1960

1980

2000

2010
11

Philip Crosby
1926-2001

Doing it right the first time

THE FOUR ABSOLUTES
Quality is conformance to requirements
The system of Quality is prevention.
The performance standard is zero defects
The measurement of quality is the price of
non-conformity.

Who sets the requirements?

Regulators
Respected Authority
Professional Bodies
Customers
Internal Audit
January 2009

12

Philip Crosby
1926-2001

Doing it right the first time

Quality is conformance to requirements
Who sets the requirements?
Regulators
Respected Authority
Professional Bodies
Customers
Internal Audit

Who does not set the requirements?

January 2009

13

Standards Development
BSI

ISO
NATO

ISO 9000
ISO 17025
ISO 15189
CDC
CLSI
WHO

ABCA

US Military
Deming
Shewhart
January 2009

THE
WORLD

14

Standards and
Quality Management
Facilities
Organization
&
Management

Customer
Satisfaction

Personnel

Quality
Management

Continual
Improvement

Documentation
&
Control

Technical
Assessment

January 2009

15

Standards and
Quality Management
Environment and
Safety
Responsibility
Authority

Facilities
Organization
&
Management

Personnel

Quality
Management

Customer
Satisfaction

Continual
Improvement

January 2009

Monitor
Audit
Review

Documentation
&
Control

Technical
Assessment

Training and
Competency

Policy
Process
SOPs
Supply Chain
Inventory
Equipment
Testing
Collection
Reporting

16

What happens if you focus all your

energy on one component?
Facilities
Organization
&
Management

Customer
Satisfaction

Personnel

Quality
Management

Continual
Improvement

Documentation
&
Control

Technical
Assessment

January 2009

17

The system starts to fall apart

QUICKLY
Facilities
Organization
&
Management

Customer
Satisfaction

Personnel

Quality
Management

Continual
Improvement

Documentation
&
Control

Technical
Assessment

January 2009

18

Quest Labs Path to Success

ISO 9001: 2000

January 2009

19

Quest Labs Path to Success

Six Sigma

ISO 9001: 2000

January 2009

20

Quest Labs Path to Success

LEAN
Six Sigma

ISO 9001: 2000

January 2009

21

CLSI Quality Management

HS01:2001

January 2009

22

Quality Assistance
Public
Laboratorians

Industry
Medical
Laboratory
Quality
Accreditation
Proficiency
Testing

Standards
Development
Organizations

al
Lean
u
n
i
t
t
n
n
a
o
m
C veme Six Sig
ro
RISK
p
m
I
Metrics FMEA
s
c
Statisti

xx
o
b
l
o
o
o
T
b
l
lliittyy Too
a
u
Q
e
a
h
u
TThe Q
January 2009

23

The silent diagnosis

The Unknown

As we know,
There are known knowns.
There are things we know we know.
We also know
There are known unknowns.
That is to say
We know there are some things
We do not know.

But there are also unknown unknowns,

The ones we don't know
We don't know.
Donald Rumsfeld
Department of Defense news briefing
Feb. 12, 2002

January 2009

24

An effective quality management system

Defends against
The Unknown Unknown

January 2009

25

Over this series we will look

at

Quality Management
Quality Management Quality Partners and Standards
The Quality Tool Box
Assessment and the Medical Laboratory

January 2009

26